New Biosimilar Approved for Neulasta
On Nov. 28, 2025, the US Food and Drug Administration (FDA) approved Lupin’s biosimilar to Amgen’s Neulasta® (pegfilgrastim), Armlupeg™ (pegfilgrastim-unne) 6mg/0.6mL injection. It is indicated to decrease the risk of infections in patients receiving cancer drugs that interfere with the bone marrow’s production of blood cells and that are associated with a clinically significant incidence of febrile neutropenia, an adverse effect of some chemotherapies. Pegfilgrastim is a PEGylated form of the granulocyte colony-stimulating factor (G-CSF) analog filgrastim, giving it a longer duration of action. G-CSF causes cells in bone marrow to produce more neutrophils. Along with the brand product, other biosimilars – Fulphila® (pegfilgrastim-jmdb – Mylan/Biocon), Nyvepria™(pegfilgrastim-apgf – Pfizer), Udenyca® (pegfilgrastim-cbqv – Coherus BioSciences), Ziextenzo®(pegfilgrastim-bmez – Sandoz), Fylnetra® (pegfilgrastim-pbbk – Amneal Pharmaceuticals) – already are available in the US. None of the biosimilars are interchangeable with Neulasta or with each other, however. Pegfilgrastim products generated $1.3 billion in US sales for the 12 months ending September 2025.
FDA Expands Omlyclo Dosing Options with 300mg Strength Approval
The FDA approved another strength of Celltrion’s Xolair® (Novartis) biosimilar, Omlyclo®(omalizumab-igec), on Dec. 1, 2025. Initially approved in March 2025 as 75mg/0.5mL and 150mg/mL single-dose prefilled syringes for subcutaneous (SC) injection, a new 300mg/2mL single-dose prefilled syringe is now approved. Like Xolair, Omlyclo is indicated for moderate-to-severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy and chronic spontaneous urticaria (CSU). Although not yet launched, Omlyclo is the first interchangeable biosimilar to Xolair. The recommended administration is a SC injection every two or four weeks, depending on the indication and IgE levels. Omlyclo carries a boxed warning for anaphylaxis; initial doses should be administered in a healthcare setting.
FDA Grants Full Approval and Expanded Indication for Jaypirca
On Dec. 3, 2025, the FDA approved Eli Lilly’s Jaypirca® (pirtobrutinib), the first and only non-covalent, reversible covalent Bruton tyrosine kinase (BTK) inhibitor, for the treatment of adults who have relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who previously received a covalent BTK inhibitor (ibrutinib, acalabrutinib or zanubrutinib). This approval expands Jaypirca’s use to patients earlier in treatment and converts its December 2023 accelerated approval for later-line CLL/SLL to full approval. The oral therapy offers continued BTK pathway inhibition even after resistance to covalent BTK inhibitors. Approval was supported by the BRUIN-CLL-321 study that showed improved median progression-free survival to 11.2 months versus 8.7 months with idelalisib plus a rituximab product or bendamustine plus a rituximab product. The prescribing information includes warnings for infections, bleeding, cytopenias, cardiac arrhythmias, secondary malignancies, hepatotoxicity and embryo-fetal toxicity. The recommended dose is 200mg orally once daily until disease progression or unacceptable toxicity. Here is the updated prescribing information.
Axogen’s Avance Nerve Scaffold Approved
The FDA approved Axogen’s Avance® (acellular nerve allograft-arwx), an off-the-shelf processed human nerve allograft designed to bridge severed peripheral nerves, on Dec. 3, 2025. Peripheral nerve injuries occur when nerves outside the brain and spinal cord are damaged. These nerves transmit signals between the central nervous system and the rest of the body, enabling movement, sensation and essential bodily functions. Avance is indicated for sensory nerve discontinuities, breaks in the pathway of sensory nerves, up to 25mm in adults and pediatric patients aged one month and older. It also received accelerated approval for larger sensory nerve gaps (>25mm), as well as motor and mixed nerve discontinuities. Unlike traditional autografts, Avance uses processed donor nerve tissue that preserves the natural structure for regeneration while eliminating the need for harvesting healthy nerves from the patient. Current alternatives include autografts, which require removing nerve tissue from another part of the body. Clinical trials demonstrated non-inferiority to collagen nerve cuffs for sensory function recovery, with common adverse reactions including procedural pain and heightened sensitivity to stimuli such as touch and pain. Previously classified as donated human tissue, Avance now holds a biologics license and is expected to have a commercial launch early Q2 2026.
Breyanzi Gets New Indication Serving as First CAR-T Approved for Marginal Zone Lymphoma
On Dec. 4, 2025, the FDA approved Bristol Myers Squibb’s Breyanzi® (lisocabtagene maraleucel) suspension for intravenous (IV) infusion for the treatment of adults who have relapsed or refractory marginal zone lymphoma (MZL) after at least two prior lines of systemic therapy, marking its fifth indication. MZL is a subtype of non-Hodgkin lymphoma that accounts for about 7% of cases, which often relapses after initial remission, and can occasionally transform into aggressive diffuse large B-cell lymphoma. Breyanzi, an autologous chimeric antigen receptor modified T-cell (CAR-T) therapy, targets the CD19 antigen expressed by many B-cell malignancies and offers a personalized approach by reprogramming a patient’s own T cells to target and destroy cancer cells. Approval was based on pivotal clinical trial results demonstrating an overall response rate of 85%, with 60% achieving complete remission and a median duration of response exceeding 12 months. The recommended dose is a single infusion following lymphodepleting chemotherapy. Initially FDA approved in February 2021, it also treats adults who have relapsed or refractory (r/r) diffuse large B-cell lymphomas (DLBCL) that have not responded to at least one other type of systemic treatment. Additionally, it has approvals as third- or later-line therapy for adults who have r/r CLL/SLL, r/r follicular lymphoma (FL) and mantle cell lymphoma (MCL). Prescribing information includes boxed warnings for cytokine release syndrome and neurological events and T-cell cancers that may be related to its use, requiring administration in certified healthcare settings. Here is the updated prescribing information.
Advancing Kidney Care: Emerging Therapies for IgA Nephropathy Issues Document Available
The Emerging Therapeutics team has released a review and pipeline document focused on IgA nephropathy (IgAN), highlighting recent advances in treatment, new FDA approvals, and promising agents in development. This comprehensive resource covers the latest KDIGO 2025 guideline updates, approved therapies and investigational drugs targeting key disease pathways. The document is attached.